FDA issued the document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”. The exemptions cover a many types of devices. The document is at the link provided.
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!